Effect of metformin on outcomes of hyperglycemia, inflammatory markers, asthma control test (ACT) and spirometry in patients with concurrent asthma and metabolic syndrome

Effect of metformin on outcomes of hyperglycemia, inflammatory markers, asthma control test (ACT), and spirometry in patients with concurrent asthma and metabolic syndrome.

A clinical trial with a control group, with parallel groups, double-blind. Randomization in two intervention and control groups as block randomization in blocks of 4 by using the sealedenvelope website, phase 3 with a sample size of 110 samples, two study groups of 55 people.

Patients will receive standard treatment for severe asthma attacks based on random allocation using blockade treated with metformin 500 mg in the form of tablets or placebo of Pharmed Company with the same shape in Imam Khomeini Hospital in Sari. The drug will start by giving one pill on the first day and will increase to one pill twice a day on the third day. This dose will continue until the end of the three-month follow-up period. The study is two-sided blind and the patient and the nurse delivering the medicine in the internal ward and the evaluating physician do not know the type of medicine. Demographic and clinical characteristics of patients at the time of hospitalization and during serial visits to pulmonary and endocrine clinics of Touba Center will be recorded by a physician using a checklist containing information about patients.

Inclusion criteria for all patients 18 years and older with severe asthma attack admitted to Imam Khomeini Hospital in Sari who also have metabolic syndrome at the same time.

The intervention group includes people with asthma and metabolic syndrome at the same time, one group receiving metformin and another group receiving placebo metformin.

Blood sugar, inflammatory markers, asthma control test, spirometry.

Randomization in intervention and control groups will be done as block randomization in blocks of 4 by using the sealedenvelope website (online randomization website). The output of the software is A and B, one for intervention and the other one for control group. In this way, the samples are divided into two intervention and control groups. The second colleague communicates with the first colleague using central randomization based on the order in which the participants entered the study and asks about the random assignment of the participant to a specific group.

Metformin or metformin placebo will be coded in sealed envelopes by a project partner, other than the treating physician. Placebo is designed as pills that are similar in shape, size and color to the original Metformin drug.

Due to the novelty of this study and the lack of other similar articles, for the sake of transparency of the study, the initial data of the project can be shared as an Excel file after de-identifying people.

The data access period is six months after the results are published.

Researchers working in academic and scientific institutions can access the data.

The use of these data in articles and scientific research is allowed.

To receive the data, send an email to hmehravaran@mazums.ac.ir, which belongs to Dr. Hossein Mehravaran.

After sending the applicant's personal details and scientific background and information related to the study, including the purpose of the study, it will be checked and if approved, the information will be provided to the person.